Yoga in Improving Quality of Life in Patients With Non-small Cell Lung Cancer Undergoing Treatment

NCT ID: NCT02895503

Last Updated: 2016-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-08-31

Brief Summary

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The purpose of this research study is to evaluate the effects of yoga (including breathing exercises) on the quality of life in patients, diagnosed and undergoing standard treatments for non-small cell lung cancer.

Detailed Description

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This clinical trial studies yoga in improving quality of life in patients with non-small cell lung cancer undergoing treatment. Yoga may help improve quality of life and pulmonary functional capacity in patients with non-small cell lung cancer.

Conditions

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Non-small Cell Lung Cancer Recurrent Non-Small Cell Lung Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm I (yoga)

Patients undergo traditional medical treatment, participate in yoga comprising basic postures and breathing exercises 3-4 times per week, and attend yoga class once weekly over 30-60 minutes for 12 weeks.

Group Type EXPERIMENTAL

Yoga

Intervention Type BEHAVIORAL

Participate in yoga

FACT-L

Intervention Type OTHER

This is a 44-item self-report instrument which measures multidimensional HRQOL. There are 5 sections dealing with physical, family, emotional, and functional well-being and their relationship with the doctor. There are nine questions in a sixth subscale that are specific to lung cancer (LSC), including shortness of breath, cough, etc. The TOI is the sum of the scores on the LCS and the physical well-being and functional well-being subscales of the FACT-L scale. The FACT-L has been shown to be reliable and valid and sensitive. (Cella, Bonomi, Lloyd, DS, Kaplan, \& Bonomi, 1995). The instrument has been used with patients with lung cancer in the Massey Cancer Center.

Pulmonary function test

Intervention Type OTHER

The pulmonary function test includes forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1) and peak expiratory flow rate (PEFR). Use of a digital spirometer provides an objective and reliable measure of the patient's vital capacity.

Arm II (emotional support group therapy)

Patients undergo traditional medical treatment and participate in emotional support group therapy with a chaplain to work on mind-body therapies comprising guided imagery and spirituality once weekly for 12 weeks.

Group Type ACTIVE_COMPARATOR

Support Group Therapy

Intervention Type BEHAVIORAL

Participate in emotional support group therapy

FACT-L

Intervention Type OTHER

This is a 44-item self-report instrument which measures multidimensional HRQOL. There are 5 sections dealing with physical, family, emotional, and functional well-being and their relationship with the doctor. There are nine questions in a sixth subscale that are specific to lung cancer (LSC), including shortness of breath, cough, etc. The TOI is the sum of the scores on the LCS and the physical well-being and functional well-being subscales of the FACT-L scale. The FACT-L has been shown to be reliable and valid and sensitive. (Cella, Bonomi, Lloyd, DS, Kaplan, \& Bonomi, 1995). The instrument has been used with patients with lung cancer in the Massey Cancer Center.

Pulmonary function test

Intervention Type OTHER

The pulmonary function test includes forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1) and peak expiratory flow rate (PEFR). Use of a digital spirometer provides an objective and reliable measure of the patient's vital capacity.

Interventions

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Yoga

Participate in yoga

Intervention Type BEHAVIORAL

Support Group Therapy

Participate in emotional support group therapy

Intervention Type BEHAVIORAL

FACT-L

This is a 44-item self-report instrument which measures multidimensional HRQOL. There are 5 sections dealing with physical, family, emotional, and functional well-being and their relationship with the doctor. There are nine questions in a sixth subscale that are specific to lung cancer (LSC), including shortness of breath, cough, etc. The TOI is the sum of the scores on the LCS and the physical well-being and functional well-being subscales of the FACT-L scale. The FACT-L has been shown to be reliable and valid and sensitive. (Cella, Bonomi, Lloyd, DS, Kaplan, \& Bonomi, 1995). The instrument has been used with patients with lung cancer in the Massey Cancer Center.

Intervention Type OTHER

Pulmonary function test

The pulmonary function test includes forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1) and peak expiratory flow rate (PEFR). Use of a digital spirometer provides an objective and reliable measure of the patient's vital capacity.

Intervention Type OTHER

Other Intervention Names

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Yoga Therapy Functional Assessment of Cancer Therapy - Lung FVC, FEV1, PEFR forced vital capacity, forced expiratory volume in 1 second, peak expiratory flow rate

Eligibility Criteria

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Inclusion Criteria

* Patients with any type of non-small cell lung cancer who are undergoing medical treatment, including surgery, radiation and / or chemotherapy.

Exclusion Criteria

* Metastasis to the brain, problems during surgery leading to myocardial infarction or hemorrhage, cerebral infarction or hemorrhage, respiratory failure, non-healing surgical wound.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mary S Shall, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2015-01818

Identifier Type: REGISTRY

Identifier Source: secondary_id

MCC-13850

Identifier Type: -

Identifier Source: org_study_id

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